Water shock wave balloon based on water hammer effect and medical equipment

Abstract

The invention discloses a water shock wave balloon based on a water hammer effect and medical equipment. The water shock wave balloon comprises a catheter, the catheter at least comprises a guide wire cavity and a medium cavity, a guide wire is arranged in the guide wire cavity in a penetrating mode, liquid flows in the medium cavity, and a valve is arranged at the far end of the medium cavity; the balloon is connected to the far end of the catheter and communicated with the medium cavity; the control part is connected to the near end of the catheter and matched with the valve to jointly control the flowing state of the liquid in the balloon and the pressure state in the balloon; when the liquid is instantly stopped when flowing in the balloon and / or the pressure in the balloon suddenly rises, the liquid forms a positive water hammer effect in the balloon; when the stopped liquid in the balloon quickly leaves the balloon and / or the pressure in the balloon is suddenly reduced, the liquid forms a negative water hammer effect in the balloon, so that positive and negative water hammer effects are formed in the balloon by utilizing the incompressibility of the liquid and through the matching of the control part and the valve, and the treatment of vascular calcification is realized.

Description

Technical Field

[0001] The present invention relates to a water shock wave balloon based on the water hammer effect, and also relates to medical equipment using the water shock wave balloon, belonging to the technical field of medical equipment. Background Art

[0002] Vascular calcification is a systemic vascular disease characterized by a dynamic vascular lesion characterized by a series of pathological changes such as the uneven deposition of minerals such as hydroxyapatite in morphology and chemical composition. All components of the vascular intima and media can undergo abnormal mineralization. The interaction between cells and non-cellular components induces the deposition of calcifications in the blood vessel walls, resulting in decreased elasticity of the blood vessel walls and impaired integrity of the vascular structure, which in turn triggers a series of adverse clinical events. With the aging of the population and the increasing prevalence of metabolic diseases, the prevalence of vascular calcification is increasing. Once calcification occurs in the blood vessels, it is difficult to reverse. Currently, the conventional approach to vascular calcification is to use balloon dilation, laser ablation or rotary resection of plaques.

[0003] In the Chinese invention with patent number ZL 202310335427.6, a shock wave balloon catheter is disclosed. This technical solution includes a first catheter, a first balloon, an operating end, a conductive wire and an operating part. The first balloon, the first catheter and the operating end are connected in sequence, the conductive wire is installed in the operating end, the first catheter and the first balloon, and a plurality of first electrode pairs are installed on the conductive wire. The proximal end of the conductive wire is provided with an operating part. During actual operation, this solution drives the conductive wire to bend and deform in the first balloon by operating the operating part, so that the first electrode pair moves toward the inner wall of the first balloon, reducing the distance between the first electrode pair and the calcified lesion. At this time, the first electrode pair unit is energized to emit a high-voltage pulse to bombard the lesion to fragment the lesion.

[0004] Similarly, the existing technologies all use high-voltage pulse discharges (up to 3000V or more) from high-energy electrodes to vaporize the surrounding liquid to form bubbles that rapidly expand and burst, producing a cavitation effect. During the cavitation process, since the particle movement speed exceeds the speed of sound in the medium, a powerful shock wave is generated. This phenomenon is also called the hydro-electric effect. The shock wave generated by the hydro-electric effect is used to impact the target calcified area to break or loosen the calcified tissue, thereby expanding the diameter of the blood vessel passage and achieving a therapeutic effect. This structure requires high-energy electrical energy to be introduced into the human body, and has high requirements for the electrical and insulation properties of the balloon and catheter. In addition, the electric pulses generated in the human body may affect the reliable operation of implanted devices (such as implantable cardiac defibrillators), posing a safety hazard. Summary of the Invention

[0005] The primary technical problem to be solved by the present invention is to provide a water shock wave balloon based on the water hammer effect.

[0006] Another technical problem to be solved by the present invention is to provide a medical device.

[0007] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0008] According to a first aspect of an embodiment of the present invention, a water shock wave balloon based on a water hammer effect is provided, comprising:

[0009] A catheter, the catheter comprising at least a guidewire cavity and a medium cavity, wherein the guidewire cavity is used to pass a guidewire, the medium cavity is used to flow a liquid, and a valve is provided at the distal end of the medium cavity;

[0010] a balloon connected to the distal end of the catheter and communicating with the medium cavity;

[0011] a control unit connected to the proximal end of the catheter and cooperating with the valve to jointly control the flow state of the liquid in the balloon and the pressure state in the balloon;

[0012] Among them, when the liquid is instantly intercepted while flowing in the balloon and / or the pressure in the balloon suddenly increases, the liquid forms a positive water hammer effect in the balloon, thereby transferring the water pressure inside the balloon to the inner wall of the balloon; when the intercepted liquid in the balloon quickly leaves the balloon and / or the pressure in the balloon suddenly decreases, the liquid forms a negative water hammer effect in the balloon, thereby transferring the external pressure to the outer wall of the balloon.

[0013] Preferably, the medium cavity includes a liquid inlet cavity and a liquid outlet cavity, and the liquid inlet cavity and the liquid outlet cavity are respectively connected to an external liquid supply device, so that the liquid can circulate between the balloon and the liquid supply device;

[0014] The valve is made of a shape memory alloy in an annular structure and is sleeved on the catheter near the entrance of the liquid outlet cavity. The valve can deform when powered, thereby blocking the entrance of the liquid outlet cavity.

[0015] The catheter further includes a wire cavity, in which a wire is passed. The control unit is electrically connected to the valve via the wire to control the power-on state of the valve.

[0016] When the control unit controls the valve to cut off power, the valve maintains its initial state so that the liquid is in a uniform flow state; when the control unit controls the valve to turn on power, the valve deforms and blocks the entrance of the liquid outlet cavity so that the liquid is in an instantaneous stop state.

[0017] Preferably, the medium cavity is a single cavity, the valve is a sealing film provided at the distal end of the medium cavity, and a cutting opening is provided on the surface of the sealing film;

[0018] The control unit includes a pressure chamber, a piston, and a driver; the pressure chamber is connected to the proximal end of the catheter and communicates with the medium chamber, and is used to store liquid; the piston is movably installed in the pressure chamber to increase or decrease the pressure in the pressure chamber; the driver is connected to the piston and is used to drive the piston to reciprocate along the longitudinal direction of the pressure chamber;

[0019] When the driver drives the piston to quickly approach the catheter, the liquid in the pressure chamber can instantly break through the sealing membrane and enter the balloon, so that the liquid forms a positive water hammer effect in the balloon under the action of high pressure;

[0020] When the driver drives the piston to quickly move away from the catheter, the liquid in the balloon can instantly break through the sealing membrane and enter the pressure chamber, so that the liquid in the balloon forms a negative water hammer effect under the action of low pressure.

[0021] Preferably, the medium cavity is a single cavity, the valve is a sealing film provided at the distal end of the medium cavity, and a cutting opening is provided on the surface of the sealing film;

[0022] The control unit includes a constant pressure chamber and an air supply device. The constant pressure chamber is connected to the proximal end of the catheter and communicates with the medium cavity. The constant pressure chamber is used to store liquid. An air inlet and an air outlet are provided on the constant pressure chamber. The air inlet is communicated with the air supply device and is used to ventilate the constant pressure chamber so that the constant pressure chamber maintains a set pressure. The air outlet is used to exhaust air to reduce the pressure in the constant pressure chamber.

[0023] When the air supply device is turned on and the exhaust port is closed, the pressure in the constant pressure chamber instantly reaches the set pressure, so that the liquid in the constant pressure chamber can instantly break through the sealing membrane and enter the balloon, thereby forming a positive water hammer effect in the balloon under the action of high pressure;

[0024] When the air supply device is closed and the exhaust port is opened, the pressure in the constant pressure chamber drops instantly, so that the liquid in the balloon can instantly break through the sealing membrane and enter the constant pressure chamber, thereby causing the liquid to form a negative water hammer effect in the balloon under the action of low pressure.

[0025] Preferably, there are two control units, and the pressure chambers of the control units are respectively connected to the medium cavity of the catheter to control the pressure inside the balloon respectively; liquid is stored in the pressure chamber of one of the control units, and liquid is not stored in the pressure chamber of the other control unit, so that the two control units alternately pressurize or depressurize the balloon.

[0026] Preferably, the piston driving portion includes at least one of a screw controlled by a stepping motor, a crankshaft structure controlled by a motor, a pneumatic structure released and removed by an inert gas, or an eccentric rotor driven by a motor.

[0027] Preferably, the outer side of the balloon has a woven layer to reduce the elastic deformation of the balloon itself.

[0028] Preferably, the outer wall of the balloon is provided with hard protrusions for resisting the plaque;

[0029] The hard protrusions include at least one of spinous processes, mastoid processes, cutting stripes or chocolate patches.

[0030] Preferably, the catheter is made of a single polymer material, a mixed polymer material, or a mixed material of a polymer material and a metal wire;

[0031] The balloon is one of a compliant expansion balloon, a semi-compliant expansion balloon or a non-compliant expansion balloon.

[0032] According to a second aspect of an embodiment of the present invention, a medical device is provided, comprising the above-mentioned water shock balloon.

[0033] Compared to existing technologies, the present invention utilizes the incompressibility of liquids and the water hammer effect to achieve vascular calcification treatment in two ways. On the one hand, a valve is designed at the entrance of the liquid outlet chamber. The valve opening and closing is precisely controlled by a control unit, causing the liquid in the balloon to form a positive or negative water hammer effect, which breaks up the plaque with the impact force of the balloon. On the other hand, a piston or gas pressurization is used to inject liquid into the balloon at high pressure. In conjunction with the sealing membrane at the distal end of the medium chamber, positive and negative water hammer effects are also formed within the balloon, rupturing the plaque with the impact of the balloon, achieving the purpose of treating vascular calcification. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic structural diagram of a water shock wave balloon based on the water hammer effect provided by the first embodiment of the present invention;

[0035] Figure 2 A cross-sectional view of a catheter in the first embodiment of the present invention;

[0036] Figure 3 This is a schematic structural diagram of the control unit and the catheter in the first embodiment of the present invention;

[0037] Figure 4 A schematic structural diagram of a water shock wave balloon based on the water hammer effect provided by the second embodiment of the present invention;

[0038] Figure 5 A cross-sectional view of a catheter in a second embodiment of the present invention;

[0039] Figure 6 A schematic structural diagram of a water shock wave balloon based on the water hammer effect provided by the third embodiment of the present invention;

[0040] Figure 7 A schematic structural diagram of a water shock wave balloon based on the water hammer effect provided in the fourth embodiment of the present invention. DETAILED DESCRIPTION

[0041] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0042] As we all know, if a pipeline valve suddenly changes from an open state to a closed state, the "water hammer effect" formed is called positive water hammer. When positive water hammer occurs, the pressure in the pressure pipe will suddenly increase, even exceeding the normal pressure in the pipe by dozens to hundreds of times, causing very large stress on the pipe wall. Conversely, if a closed valve is suddenly opened, a "water hammer effect" will also occur. This situation is called negative water hammer. When negative water hammer occurs, the pressure in the pipe suddenly decreases. The stress transfer change may create an unfavorable vacuum in the pipe. Under the influence of external air pressure, the pipe may suddenly collapse.

[0043] The technical concept in the embodiments of the present invention is: to utilize the incompressibility and water hammer effect of the liquid, by controlling the flow state of the liquid in the balloon and the pressure state in the balloon, so that the liquid in the balloon undergoes a positive water hammer effect or a negative water hammer effect, and then transmits the pressure to the calcified plaque, impacting the plaque to produce cracks and eventually rupture.

[0044] In different embodiments of the present invention, the above technical concept is realized by designing a variety of structures. The specific structure of each embodiment is described in detail below.

[0045] First embodiment

[0046] like Figure 1 As shown, the first embodiment of the present invention provides a water shock balloon based on the water hammer effect, comprising a catheter 1, a balloon 2, a control unit 3 and a valve 4. Figure 2 As shown, the catheter 1 is a multi-lumen tube for passing a guide wire 10 and flowing liquid, and the catheter 1 is also provided with a valve 4 for controlling the flow state of the liquid (such as Figure 3 As shown in FIG. 1 , the balloon 2 is connected to the distal end of the catheter 1 (the end away from the doctor's operation is referred to as the distal end in this embodiment) and communicates with the medium cavity, allowing liquid to enter the balloon 2 through the catheter 1. The control unit 3 is connected to the proximal end of the catheter 1 (the end closest to the doctor's operation is referred to as the proximal end in this embodiment) and cooperates with the valve to jointly control the flow state and pressure state of the liquid in the balloon 2, thereby causing the liquid to form a positive water hammer effect or a negative water hammer effect in the balloon 2.

[0047] Specifically, in the present embodiment, the catheter 1 is a hollow catheter structure, which is in the shape of a circular tube as a whole. The catheter 1 is provided with a guidewire cavity 101, a wire cavity 102 and a medium cavity that penetrate the catheter in the longitudinal direction, wherein a guidewire 10 is passed through the guidewire cavity 101 for guiding the insertion of the catheter 1. A wire 20 is passed through the wire cavity 102 for electrically connecting to the valve 4 (described in detail below). The medium cavity includes a liquid inlet cavity 103 and a liquid outlet cavity 104, and the liquid inlet cavity 103 and the liquid outlet cavity 104 are respectively connected to an external liquid supply device so that the liquid can circulate between the balloon and the liquid supply device. Optionally, the catheter 1 is made of a single polymer material, a mixed polymer material or a mixed material of a polymer material and a metal wire.

[0048] like Figure 1 As shown, the balloon 2 is arranged at the distal end connected to the catheter 1 and is in communication with the liquid inlet cavity 103 and the liquid outlet cavity 104, so that liquid is filled into the balloon 2 through the liquid inlet cavity 103 and the liquid is discharged from the balloon 2 through the liquid outlet cavity 104. Optionally, the balloon 2 is one of a compliant expansion balloon, a semi-compliant expansion balloon or a non-compliant expansion balloon. Optionally, the length of the balloon 2 is 1 to 99 mm, the diameter is 1 to 99 mm, and the pressure resistance range is 0.1 to 999 ATM. More preferably, the outer surface of the balloon 2 is provided with hard protrusions 21, such as spinous processes, mastoid processes, cutting stripes, chocolate patches and other design structures that help pressure focusing. More preferably, the outer side of the balloon 2 has a woven layer to reduce the elastic deformation of the balloon itself.

[0049] like Figure 3 As shown, in this embodiment, the valve 4 is made of a shape memory alloy in an annular structure, and is sleeved on the inlet 1041 of the conduit 1 near the liquid outlet cavity 104. Specifically, in this embodiment, the valve 4 includes a fixed section 41, a pleated section 42 and a movable section 43. Among them, the fixed section 41 is fixed to the outer surface of the conduit 1; the movable section 43 can move back and forth along the axial direction of the conduit 1; the pleated section 42 is connected between the fixed section 41 and the movable section 43, and is preformed by a shape memory alloy. When the valve 4 is energized, the pleated section 42 will be deformed by heat, thereby driving the movable section 43 to gradually approach the inlet 1041 of the liquid outlet cavity until the inlet 1041 of the liquid outlet cavity is blocked (i.e.: Figure 3 The movable section 43 moves from the solid line position to the dotted line position). When the valve 4 is powered off, the pleated section 42 returns to its original state, thereby driving the movable section 43 to gradually move away from the inlet 1041 of the liquid outlet cavity (i.e.: Figure 3 The middle movable section 43 moves from the dotted line position to the solid line position). Accordingly, the control unit 3 is electrically connected to the valve 4 via the wire 20, so that the power-on state of the valve 4 is controlled by the control unit 3.

[0050] It is understood that when the control unit 3 controls the valve 4 to be de-energized, the inlet 1041 of the liquid outlet cavity is opened, allowing the liquid to flow at a constant speed. When the control unit 3 controls the valve 4 to be energized, the movable section 43 blocks the inlet of the liquid outlet cavity, causing the liquid to be momentarily stopped, thereby generating a positive water hammer effect within the balloon 2, thereby transmitting the internal water pressure of the balloon 2 to the inner wall of the balloon. Furthermore, when the control unit 3 controls the valve 4 to be de-energized, the inlet 1041 of the liquid outlet cavity is opened, and the liquid flows out of the inlet 1041 rapidly, thereby generating a negative water hammer effect within the balloon 2, thereby transmitting the external pressure to the outer wall of the balloon.

[0051] In this embodiment, the pressure generated by the water hammer effect is calculated using the following formula:

[0052] ΔP=ρ*α*ΔV, where

[0053] ΔP represents the pressure increase due to the water hammer effect (unit: Pa, Pascal);

[0054] ρ represents the density of the liquid, for example, the density of water is 1000 kg / m3;

[0055] α represents the propagation speed of the pressure wave in the pipe, which is generally the speed of sound;

[0056] ΔV represents the change in liquid velocity.

[0057] Therefore, by controlling the flow rate of the liquid when it flows at a uniform speed, the pressure generated by the corresponding positive water hammer effect can be calculated so that the pressure can meet the requirements of destroying plaques without damaging the blood vessel wall.

[0058] The working process of the water shock balloon is described in detail below:

[0059] ① The water shock balloon is delivered to the location of vascular calcification via the guide wire 10. At this time, the balloon 2 is in a contracted state to facilitate overall delivery.

[0060] ② Liquid is continuously added into the balloon 2 through the liquid supply device until the balloon 2 expands to fit the blood vessel wall. At this time, the balloon 2 is in the initial state, the internal pressure is A, and the liquid flows at a uniform speed between the balloon 2 and the liquid supply device.

[0061] ③ By controlling valve 4 to be energized via control unit 3, the flow of liquid within balloon 2 is suddenly stopped, causing the pressure within balloon 2 to rapidly increase. Depending on the liquid flow rate setting, the increased pressure value can reach over 400A. After reaching the peak pressure, the pressure is released through balloon 2 and liquid inlet chamber 103. Because the opening of liquid inlet chamber 103 is extremely small (typically 0.1mm to 0.15mm) and water is still flowing in, most of the pressure release occurs within balloon 2, resulting in a positive water hammer effect within balloon 2. Thus, by transmitting pressure to balloon 2, the hard protrusions on balloon 2 are used to squeeze the calcified area of the blood vessel.

[0062] ④ After a preset duration (e.g., 1 second), the control unit 3 controls the valve 4 to be de-energized again, thereby allowing the liquid in the balloon 2 to quickly flow out of the balloon 2, causing the pressure in the balloon 2 to drop rapidly. During this process, a negative water hammer effect occurs in the balloon 2 due to the negative pressure, allowing the vascular calcification area to gradually return to its original state;

[0063] ⑤ Repeat the above process ③ to ④, and after multiple impacts on the plaque, the plaque is broken. At this time, the liquid is extracted from the balloon 2 through the liquid supply device 31, so that the balloon 2 shrinks to the smallest state and is finally withdrawn from the blood vessel.

[0064] Second embodiment

[0065] like Figure 4 As shown, the second embodiment of the present invention provides a water shock balloon based on the water hammer effect, comprising a catheter 1, a balloon 2, a control unit 3, and a valve 4. The structure of the balloon 2 is the same as that of the first embodiment, and will not be repeated here.

[0066] In this embodiment, Figure 5 As shown, the catheter 1 is a hollow catheter structure, which is in the shape of a circular tube as a whole. A guidewire cavity 101 and a medium cavity 105 that pass through the catheter are provided on the catheter 1 along the longitudinal direction. Among them, a guidewire 10 is passed through the guidewire cavity 101 for guiding the insertion of the catheter 1. The medium cavity 105 is a single cavity, and the valve 4 is a sealing film arranged at the distal end of the medium cavity 105, and a cut-line opening 44 (for example: a cross-shaped cut) is provided on the surface of the sealing film. Optionally, the catheter 1 is made of a single polymer material, a mixed polymer material, or a mixed material of a polymer material and a metal wire.

[0067] Furthermore, it is understandable that in this embodiment, the material and thickness of the sealing film need to meet certain requirements. For example, through the functional components such as the image transducer and the pressure sensor provided on the catheter 1, the values such as the thickness of the plaque in the blood vessel and the blood vessel pressure are obtained, and then the expected pressure value of the water hammer effect is determined based on the plaque thickness and the blood vessel pressure. Based on the expected pressure value, the water flow velocity can be obtained by the pressure calculation formula of the water hammer effect mentioned above. Therefore, the water flow velocity is used as the critical velocity, and a suitable material (for example, rubber) and thickness are selected so that when the water flow is greater than or equal to the critical velocity, the incision 44 can be opened, but the water flow less than the critical velocity cannot open the incision 44, thereby ensuring that the pressure generated by the water hammer effect meets the requirements of squeezing the plaque.

[0068] like Figure 4 As shown, the control unit 3 includes a pressure chamber 301, a piston 302 and a driver 303. The pressure chamber 301 is connected to the proximal end of the catheter 1 and is in communication with the medium chamber 105. The pressure chamber 301 is used to store liquid. The piston 302 is movably mounted in the pressure chamber. The driver 303 is connected to the piston 302 to provide a driving force so that the piston 302 performs piston motion in the pressure chamber 301. The pressure chamber 301 includes a medium hole 3011. The medium hole 111 is provided on the side of the pressure chamber 301 that does not cooperate with the piston 302 and is a hole structure that penetrates the wall thickness of the pressure chamber 301. As the pressure chamber 301 and the piston 302 move as pistons, the medium (e.g., water) in the pressure chamber 301 and the catheter 1 enters the pressure chamber 301 or the catheter 1 through the medium hole 111.

[0069] In this embodiment, the pressure chamber 301 and the piston 302 can withstand and output a medium pressure of 0.1 to 999 ATM. Optionally, the pressure chamber 301 and the piston 302 are made of a polymer material. Optionally, the pressure chamber 301 and the piston 302 are made of a metal material.

[0070] like Figure 4 As shown, in this embodiment, the driver 303 includes an eccentric rotor 3031 and a connecting rod 3032. The distal end of the connecting rod 3032 is rotatably connected to the piston 302, and the proximal end is rotatably connected to the eccentric rotor 3031. When the eccentric rotor 3031 rotates, the connecting rod 3032 can drive the piston 302 to reciprocate, thereby changing the internal pressure of the balloon 2. Optionally, the eccentric rotor 3031 can be driven to rotate by a motor.

[0071] Optionally, the driver 303 is a screw rod controlled by a stepper motor, which can drive the piston 302 to reciprocate. Optionally, the driver 303 is a crankshaft structure controlled by a motor. Optionally, the driver 303 is a pneumatic structure that releases and removes inert gas.

[0072] It is understood that when the driver 303 drives the piston 302 to rapidly approach the catheter 1, the liquid in the pressure chamber 301 can instantly break through the tangent line 44 of the sealing membrane and enter the balloon 2, thereby causing the liquid to form a positive water hammer effect within the balloon under the action of high pressure. When the driver 303 drives the piston 302 to rapidly move away from the catheter 1, the liquid in the balloon 2 can instantly break through the tangent line 44 of the sealing membrane and enter the pressure chamber 301, thereby causing the liquid to form a negative water hammer effect within the balloon 2 under the action of low pressure.

[0073] The working process of the water shock balloon is described in detail below:

[0074] ① When the piston 302 is located at the distal end of the pressure chamber 301 (the piston is extended), the pressure chamber 301 and the medium cavity 105 are filled with medium. At this time, the balloon 2 is in a contracted state with the minimum volume, which facilitates delivery.

[0075] ② The piston 302 moves from the distal end of the pressure chamber 301 to the proximal end (the piston retracts). Simultaneously, the inner cavity of the pressure chamber 301 is compressed, and liquid is filled into the balloon 2 through the medium cavity 105, causing the balloon 2 to expand under pressure until the outer surface of the balloon 2 contacts the plaque. At this point, the distance traveled by the piston 302 is called the expansion distance.

[0076] ③ As piston 302 continues to move toward the proximal end of pressure chamber 301, due to the incompressibility of the liquid, it breaks through the cutout 44 in the sealing membrane and enters balloon 2, causing the pressure inside balloon 2 to increase. As piston 302 stops, the liquid no longer enters balloon 2. The liquid flowing inside balloon 2 is intercepted by the sealing membrane, causing a positive water hammer effect within balloon 2. The liquid then impacts balloon 2 and, through the outer wall of balloon 2, impacts the plaque. At this point, the stroke traveled by piston 302 is called the impact stroke.

[0077] ④ After the impact stroke, piston 302 rapidly moves toward the distal end of pressure chamber 301, but does not enter the expansion stroke. This causes the pressure in balloon 2 to drop rapidly, yet still press against the plaque, preventing balloon 2 from retracting. At this point, under the negative pressure, the liquid within balloon 2 breaks through the cutout 44 on the seal membrane and enters pressure chamber 301, creating a negative water hammer effect within balloon 2.

[0078] ⑤ After the designed number of impact strokes has been repeated, balloon 2 repeatedly impacts the plaque, detaching it from the vessel wall. At this point, piston 302 returns to its expansion stroke and continues its movement toward the distal end of pressure chamber 301. As the interior of pressure chamber 301 expands, the medium flows out of balloon 2 through medium cavity 105 and into pressure chamber 301. The balloon 2 then deflates and is eventually removed from the vessel.

[0079] Third embodiment

[0080] like Figure 6 As shown, the third embodiment of the present invention provides a water shock balloon based on the water hammer effect, comprising a catheter 1, a balloon 2, a control unit 3, and a valve 4. The structures of the catheter 1, balloon 2, and valve 4 are the same as those of the second embodiment and will not be repeated here.

[0081] Compared with the second embodiment, this embodiment is different in that there are multiple control units 3 . Only the differences from the second embodiment will be described below.

[0082] Specifically, in this embodiment, there are two control units (three or more may be used in other embodiments). Furthermore, the pressure chambers 301 of each control unit 3 are respectively connected to the medium cavity 105 of the catheter 1 to control the pressure within the balloon 2. The pressure chamber 301 of the first control unit 3 stores liquid, while the pressure chamber 301 of the second control unit 3 does not, so that the two control units 3 alternately pressurize or depressurize the balloon 2.

[0083] During specific use, after the balloon 2 is pressurized through the first control unit 3, the balloon 2 needs to be depressurized through the second control unit 3; then, the balloon 2 is pressurized through the second control unit 3 and the balloon 2 is depressurized through the first control unit 3, and so on.

[0084] Except for the above differences, the rest of the structure of this embodiment is the same as that of the second embodiment and will not be described again here.

[0085] Fourth embodiment

[0086] like Figure 7 As shown, the fourth embodiment of the present invention provides a water shock balloon based on the water hammer effect, comprising a catheter 1, a balloon 2, a control unit 3, and a valve 4. The structures of the catheter 1, balloon 2, and valve 4 are the same as those of the second embodiment and are not described in detail here.

[0087] The following only describes the differences between this embodiment and the second embodiment:

[0088] Specifically, in this embodiment, the control unit 3 includes a constant pressure chamber 310 and an air supply device 320. The constant pressure chamber 310 is connected to the proximal end of the catheter 1 and is in communication with the medium cavity 105. The constant pressure chamber 310 is used to store liquid. A pressure sensor 330 is also provided on the inner wall of the constant pressure chamber 310 for detecting the pressure value in the constant pressure chamber 310. The constant pressure chamber 310 is provided with an air inlet 3101 and an air outlet 3102. The air inlet 3101 is in communication with the air supply device 320 for ventilating the constant pressure chamber so that the constant pressure chamber 310 maintains the set pressure; the air outlet 3102 is used to exhaust air to reduce the pressure in the constant pressure chamber 310.

[0089] In this embodiment, the gas supply device 320 is preferably a CO2 gas cylinder. The common gas pressure of the CO2 gas cylinder is 20~30MPA (197ATM~296ATM). In this embodiment, by setting the pressure of the CO2 gas cylinder to 6MPA, that is, around 59ATM, the CO2 gas cylinder is connected to the constant pressure chamber 310, and the constant pressure chamber 310 can quickly reach the set pressure (for example: 50ATM).

[0090] It is understood that when the air supply device 320 is turned on and the exhaust port 3102 is closed, the pressure in the constant pressure chamber 310 quickly reaches the set pressure, allowing the liquid in the constant pressure chamber 310 to instantly break through the sealing membrane and enter the balloon 2, thereby causing a positive water hammer effect in the liquid balloon 2 under the action of high pressure. Conversely, when the air supply device 320 is turned off and the exhaust port 3102 is opened, the pressure in the constant pressure chamber 310 quickly decreases, allowing the liquid in the balloon 2 to instantly break through the sealing membrane and enter the constant pressure chamber 310, thereby causing a negative water hammer effect in the balloon 2 under the action of low pressure.

[0091] The working process of the water shock balloon is described in detail below:

[0092] ① The water shock balloon is delivered to the location of vascular calcification via the guide wire 10. At this time, the balloon 2 is in a contracted state to facilitate overall delivery.

[0093] ② Temporarily connect the air supply device 302 to the constant pressure chamber 310 and close the exhaust port 3102 so that the pressure of the constant pressure chamber 310 is pre-raised to the initial pressure (for example: 4ATM), thereby filling the liquid into the balloon 2 through the medium cavity 105, causing the balloon 2 to expand under pressure until the outer surface of the balloon 2 rests against the plaque.

[0094] ③ The constant pressure chamber 310 is continuously filled with gas through the gas supply device 302, and the current pressure in the constant pressure chamber 310 is detected in real time by the pressure sensor 330. Once the current pressure in the constant pressure chamber 310 reaches the set value (e.g., 50 ATM), the gas supply device 302 is disconnected. Due to the incompressibility of the liquid, the liquid, under high pressure, breaks through the cut 44 on the sealing membrane and enters the balloon 2, causing the pressure in the balloon 2 to increase. Furthermore, as the gas supply device 302 stops filling with gas, the liquid no longer enters the balloon 2, and the liquid flowing in the balloon 2 is intercepted by the sealing membrane, causing the liquid to form a positive water hammer effect in the balloon 2, thereby using the liquid to impact the balloon 2 and, through the outer wall of the balloon 2, the plaque.

[0095] ④ After a preset time (for example, 1 second), the exhaust port 3102 is opened to rapidly reduce the pressure in the constant pressure chamber 310 until it reaches the initial pressure. The exhaust port 3102 is then closed to ensure that the outer wall of the balloon 2 remains in contact with the calcified area.

[0096] ⑤ Repeat the above process ③ to ④, and after multiple impacts on the plaque, the plaque is broken. At this time, the exhaust port 3102 is opened to extract the liquid from the balloon 2, causing the balloon 2 to shrink to its smallest state and finally withdrawn from the blood vessel.

[0097] Fifth embodiment

[0098] The fifth embodiment of the present invention provides a water shock balloon based on the water hammer effect, comprising a catheter 1, a balloon 2, a control unit 3, and a valve 4. The structures of the catheter 1, balloon 2, and valve 4 are the same as those of the second embodiment and are not described in detail here.

[0099] Compared to the second embodiment, this embodiment differs in that a pressure pump is used as control unit 3 to directly provide pressure, simplifying the overall structure of control unit 3 and facilitating the overall structural layout of the water shock balloon. The specific model and specifications of the pressure pump can be adaptively selected based on the pressure requirements and will not be elaborated on here.

[0100] In addition, based on the above-mentioned first to fifth embodiments, an embodiment of the present invention further provides a medical device, which includes any one of the above-mentioned water shock balloons.

[0101] In summary, the water shock balloon and medical device based on the water hammer effect provided by the embodiments of the present invention have the following beneficial effects:

[0102] (1) By utilizing the incompressibility and water hammer effect of the liquid, an openable and closable valve 4 is designed at the entrance of the liquid outlet cavity 104, and the opening and closing of the valve 4 is controlled by the control unit 3 to realize the formation of a positive or negative water hammer effect of the liquid in the balloon 2, and then the balloon 2 is used to impact the plaque, causing the plaque to rupture, thereby achieving the treatment of vascular calcification.

[0103] (2) By utilizing the incompressibility and water hammer effect of the liquid, the liquid is allowed to enter the balloon 2 under high pressure by piston pressurization or gas pressurization, and the sealing membrane 111 provided at the distal end of the medium cavity 105 is used to form a positive water hammer effect or a negative water hammer effect in the balloon 2, thereby using the balloon 2 to impact the plaque, causing the plaque to rupture, thereby achieving the treatment of vascular calcification.

[0104] It should be noted that the above embodiments are merely examples, and the technical solutions of the various embodiments may be combined and are all within the scope of protection of the present invention.

[0105] It should be understood that the terms "thickness", "depth", "up", "down", "horizontal", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0106] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0107] The above describes in detail the water shock balloon and medical device based on the water hammer effect provided by the present invention. For those skilled in the art, any obvious modification made to the present invention without departing from the essence of the present invention will constitute an infringement of the present invention's patent rights and will result in corresponding legal liability.

Claims

1. A water shock wave balloon based on water hammer effect, characterized in that include: A catheter, the catheter comprising at least a guidewire cavity and a medium cavity, wherein the guidewire cavity is used to pass a guidewire, the medium cavity is used to flow a liquid, and a valve is provided at the distal end of the medium cavity; a balloon connected to the distal end of the catheter and communicating with the medium cavity; a control unit connected to the proximal end of the catheter and cooperating with the valve to jointly control the flow state of the liquid in the balloon and the pressure state in the balloon; Among them, when the liquid is instantly intercepted while flowing in the balloon and / or the pressure in the balloon suddenly increases, the liquid forms a positive water hammer effect in the balloon, thereby transferring the water pressure inside the balloon to the inner wall of the balloon; when the intercepted liquid in the balloon quickly leaves the balloon and / or the pressure in the balloon suddenly decreases, the liquid forms a negative water hammer effect in the balloon, thereby transferring the external pressure to the outer wall of the balloon.

2. The water shock balloon according to claim 1, wherein: The medium cavity includes a liquid inlet cavity and a liquid outlet cavity, and the liquid inlet cavity and the liquid outlet cavity are respectively connected to an external liquid supply device so that the liquid can circulate between the balloon and the liquid supply device; The valve is made of a shape memory alloy in an annular structure and is sleeved on the conduit near the inlet of the liquid outlet cavity; the valve can deform when powered, thereby blocking the inlet of the liquid outlet cavity; The catheter further includes a wire cavity, in which a wire is passed, and the control unit is electrically connected to the valve via the wire to control the power-on state of the valve; When the control unit controls the valve to cut off power, the valve maintains its initial state so that the liquid is in a uniform flow state; when the control unit controls the valve to turn on power, the valve deforms and blocks the entrance of the liquid outlet cavity so that the liquid is in an instantaneous stop state.

3. The water shock balloon according to claim 1, wherein: The medium cavity is a single cavity, the valve is a sealing film provided at the distal end of the medium cavity, and a cutting opening is provided on the surface of the sealing film; The control unit includes a pressure chamber, a piston, and a driver; the pressure chamber is connected to the proximal end of the catheter and communicates with the medium chamber, and is used to store liquid; the piston is movably installed in the pressure chamber to increase or decrease the pressure in the pressure chamber; the driver is connected to the piston and is used to drive the piston to reciprocate along the longitudinal direction of the pressure chamber; When the driver drives the piston to quickly approach the catheter, the liquid in the pressure chamber can instantly break through the sealing membrane and enter the balloon, so that the liquid forms a positive water hammer effect in the balloon under the action of high pressure; When the driver drives the piston to quickly move away from the catheter, the liquid in the balloon can instantly break through the sealing membrane and enter the pressure chamber, so that the liquid in the balloon forms a negative water hammer effect under the action of low pressure.

4. The water shock balloon according to claim 1, wherein: The medium cavity is a single cavity, the valve is a sealing film provided at the distal end of the medium cavity, and a cutting opening is provided on the surface of the sealing film; The control unit includes a constant pressure chamber and an air supply device. The constant pressure chamber is connected to the proximal end of the catheter and communicates with the medium cavity. The constant pressure chamber is used to store liquid. An air inlet and an air outlet are provided on the constant pressure chamber. The air inlet is communicated with the air supply device and is used to ventilate the constant pressure chamber so that the constant pressure chamber maintains a set pressure. The air outlet is used to exhaust air to reduce the pressure in the constant pressure chamber. When the air supply device is turned on and the exhaust port is closed, the pressure in the constant pressure chamber instantly reaches the set pressure, so that the liquid in the constant pressure chamber can instantly break through the sealing membrane and enter the balloon, thereby forming a positive water hammer effect in the balloon under the action of high pressure; When the air supply device is closed and the exhaust port is opened, the pressure in the constant pressure chamber drops instantly, so that the liquid in the balloon can instantly break through the sealing membrane and enter the constant pressure chamber, thereby causing the liquid to form a negative water hammer effect in the balloon under the action of low pressure.

5. The water shock balloon according to claim 3, wherein: There are two control units, and the pressure chambers of the control units are respectively connected to the medium cavity of the catheter to control the pressure inside the balloon respectively; liquid is stored in the pressure chamber of one of the control units, and liquid is not stored in the pressure chamber of the other control unit, so that the two control units alternately pressurize or depressurize the balloon.

6. The water shock balloon according to claim 3, wherein: The piston driving part includes at least one of a screw controlled by a stepping motor, a crankshaft structure controlled by a motor, a pneumatic structure released and removed by inert gas, or an eccentric rotor driven by a motor.

7. The water shock balloon according to any one of claims 1 to 6, characterized in that: The outer side of the balloon has a braided layer to reduce the elastic deformation of the balloon itself.

8. The water shock balloon according to any one of claims 1 to 6, characterized in that: The outer wall of the balloon is provided with hard protrusions for resisting the plaque; wherein the hard protrusions include at least one of spinous processes, mastoid processes, cutting stripes or chocolate plaques.

9. The water shock balloon according to any one of claims 1 to 6, characterized in that: The catheter is made of a single polymer material, a mixed polymer material, or a mixed material of a polymer material and a metal wire; The balloon is one of a compliant expansion balloon, a semi-compliant expansion balloon or a non-compliant expansion balloon.

10. A medical device, characterized in that The invention comprises the water shock balloon according to any one of claims 1 to 9.

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